Pentasa 500 mg prolonged-release tablets Pentasa 1 g prolonged-release tablet is
mesalazine
What Pentasa is and what it is used for
Pentasa is used to treat mild to moderate relapses of ulcerative colitis and to prevent future relapses.
Ulcerative colitis is an inflammatory bowel disease in which the inside of the intestine becomes inflamed and develops small wounds that can bleed.
Pentasa prolonged-release tablet consists of small grains of mesalazine covered with a casing. The grains slowly release the active ingredient (mesalazine). It reduces inflammation and painful symptoms.
What you need to know before using Pentasa
Do not use Pentasa
- if you are allergic to mesalazine or any of the other ingredients of this medicine (listed in section 6)
- if you are allergic to other salicylates, such as acetylsalicylic acid
- if you suffer from severe liver and/or kidney disease
Warnings and cautions
Talk to your doctor or pharmacist before using Pentasa:
- if you are allergic to sulfasalazine (risk of allergy to salicylates)
- if you have or have previously had liver or kidney disease
- if you tend to bleed
- if you have a stomach ulcer (in the stomach or duodenum )
- if you have a lung disease (especially asthma )
- if you have ever developed severe rash or dandruff , blistering, and / or sores in your mouth after using mesalazine
Serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with mesalazine treatment. Stop using Pentasa and seek medical attention immediately if you experience any of the symptoms of these serious skin reactions described in section 4.
Kidney stones can form when using mesalazine. Symptoms may include pain in the sides of the abdomen and blood in the urine. Be sure to drink enough fluids during treatment with mesalazine.
When you are being treated with this medicine, your doctor will usually ask you to provide blood and urine tests to check your kidney function, especially at the beginning of treatment.
Other medicines and Pentasa
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is especially important if you are taking any of the following:
- certain drugs that may affect kidney function, such as NSAIDs (certain painkillers and anti-inflammatory drugs) and acetylsalicylic acid
- azathioprine (used after transplants or to treat autoimmune diseases)
- 6-mercaptopurine or thioguanine ( cytotoxic drug, used to treat leukemia )
- warfarin (blood thinner)
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
There is limited experience of use in pregnant women.
Breast-feeding
The active substance in Pentasa passes into breast milk. Newborns can experience hypersensitivity reactions such as diarrhea. If the breastfed baby develops diarrhea, breastfeeding should be stopped.
Driving and using machines
Pentasa has no known effect on the ability to drive and use machines.
How to use Pentasa
Always use Pentasa exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Adults
To treat relapses of the disease, your doctor will prescribe a dose of up to 4 g of mesalazine per day, to be taken once daily or divided into several doses. This can be taken as four Pentasa 1g tablets once daily or two Pentasa 1g tablets twice daily. Pentasa 500 mg tablets can also be used to get the dose that is best for you.
To prevent further relapses of the disease, your doctor will usually prescribe 2 g of mesalazine per day, as two Pentasa tablets 1 g once daily or four Pentasa tablets 500 mg once daily.
Use for children and adolescents
Children ≥ 6 years
Dose one depends on the weight of the child and is calculated by the doctor.
A general recommendation is half the adult dose for children weighing up to 40 kg and the normal adult dose for those weighing over 40 kg.
Pentasa prolonged-release tablets 1 g should be swallowed whole.
Pentasa 500 mg prolonged-release tablets can be divided but must not be chewed or crushed.
If the tablets are difficult to swallow, they may be slurried in 50 ml (approx. 3 tablespoons) of cold water. Stir and drink immediately.
If you use more Pentasa than you should
If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor or hospital immediately for an assessment of the risk and advice.
If you forget to use Pentasa
If you forget to take a dose, take it as soon as you remember and then take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact a doctor immediately and stop taking Pentasa if you get any of the following:
- Sudden abdominal cramps, abdominal pain, fever, severe headache, and rash ( hypersensitivity reaction to the drug).
- Severe skin changes or rashes, reddish, not raised, spots on the torso that resemble targets or are round, often with blisters in the middle, scaly skin, sores in the mouth, pharynx, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (erythema multiforme, Stevens-Johnson syndrome, or toxic epidermal necrolysis ).
- Swelling of the face, tongue, or throat, difficulty swallowing, hives and difficulty breathing, fever, and sometimes a drop in blood pressure ( Quincke’s edema or anaphylactic reaction ).
Pentasa can in very rare cases affect the white blood cells so that the defense against infection deteriorates. If you get an infection with symptoms such as fever with severe general deterioration or fever with local infection symptoms such as sore throat/throat/mouth or difficulty urinating, you should see a doctor as soon as possible so that blood tests can rule out a lack of white blood cells ( agranulocytosis ). It is important that you then have information about your medication.
These side effects are very rare and may affect up to 1 in 10,000 people.
Other side effects:
Common (may affect up to 1 in 10 people)
- diarrhea
- magnet
- nausea
- vomiting
- headache
- rash
- gas problems
Rare (may affect up to 1 in 1,000 people)
- myocarditis and pericarditis ( myocarditis and pericarditis) which can cause shortness of breath and chest pain or palpitations
- inflammation of the pancreas (symptoms include back and/or abdominal pain)
- dizziness
- increased skin sensitivity to sunlight and ultraviolet light ( photosensitivity )
Very rare (may affect up to 1 in 10,000 people)
- anemia and other blood changes (decreased number of certain blood cells which can cause bleeding, bruising, fever, and sore throat)
- drug reaction that can manifest itself as fever, rash, altered blood picture, enlarged lymph nodes, and effects on internal organs (DRESS syndrome)
- liver disease (with symptoms such as jaundice (yellowing of the skin and/or eyes) and/or slow bowel movements)
- kidney disease (with symptoms such as blood in the urine, and/or edema (swelling caused by water accumulating in the body)
- peripheral neuropathy (a condition that affects nerves in the hands and feet with symptoms such as tingling and numbness)
- allergic lung reactions, inflammation of the lung sac or scar tissue in the lungs (with symptoms such as cough, trachea, respiratory discomfort or pain, difficulty breathing, and bloody and/or extensive vomiting)
- hair loss (ceases after treatment)
- muscle and joint pain
- inflammation that can affect various parts of the body such as joints, skin, kidneys, heart, etc. (symptoms such as joint pain, fatigue, fever, abnormal or unexplained bleeding (especially nosebleeds), bruising, purple discoloration of the skin (including severe superficial sores and blisters such as can affect the skin as a protective barrier of the body))
- accumulation of fluid around the heart (shedding in the pericardium) that can cause pain or pressure over the chest
- discolored urine
- transient decrease in the number of sperm (ceases after the end of treatment)
- severe diarrhea and abdominal pain due to an allergic reaction in the gastrointestinal tract
- isolated cases of benign intracranial hypertension (benign pressure increase in the skull due to fluid accumulating around the brain) have been reported in adolescents. Symptoms include headache, nausea, vomiting, and / or visual or hearing impairment
Has been reported (occurs in an unknown number of users)
- kidney stones and kidney pain (see also section 2)
Several of the above side effects can be due to the disease itself.
How to store Pentasa
Keep this medicine out of the sight and reach of children.
Store in the original package. Sensitive to light.
Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is mesalazine. Each tablet contains 500 mg and 1g (= 1000 mg) of mesalazine, respectively.
- The other ingredients are: magnesium stearate, talc, ethylcellulose, povidone, and microcrystalline cellulose
What the medicine looks like and the contents of the pack
500 mg: Round white-gray to light brown, mottled, marked PENTASA on one side and 500 mg and break notch on the other side.
1 g: Oval white to light gray, mottled, marked PENTASA on both sides.
Pack sizes:
500 mg (blister): 1×100 prolonged-release tablets , 3×100 prolonged-release tablets , 5×100 prolonged-release tablets.
1 g (blister): 60 (6×10) prolonged-release tablets are.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Ferring Läkemedel AB
Box 4041
203 11 Malmö
040-691 69 00
Manufacturer:
Ferring GmbH
Wittland 11
DE-24109 Kiel
Germany